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T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial
Overall Recruitment Status: Active, currently enrolling
Official Title
The CompassHER2 Trials (COMprehensive use of Pathologic Response ASSessment to optimize therapy in HER2-Positive Breast Cancer): CompassHER2 Residual Disease (RD), a double-blinded, phase III randomized trial of T-DM1 and placebo compared with T-DM1 and tucatinib
Region Sponsors
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Seagen Inc.
Acronym KP IRB No.
Study Type Phase
Clinical Trial Phase III
Study Population Description
Patients with high risk, HER2 positive breast cancer
The purpose of this study is to see how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer.
Detailed Description
Primary objective: to determine if the invasive disease-free survival (iDFS) with T-DM1 and tucatinib is superior to the iDFS in the control arm (T-DM1 + placebo) when administered to high risk patients with HER2-positive breast cancer and residual disease after neoadjuvant HER2-directed therapy.
Gender Age Limit
Male & Female
Inclusion Criteria
  • Breast cancer that is clinical stage T1-4, N0-3 disease at presentation and HER2-positive
  • Received neoadjuvant chemotherapy with one of the following regimens: docetaxel/trastuzumab/pertuzumab (THP), paclitaxel/methotrexate/cisplatin (TMP), doxorubicin/cyclophosphamide/paclitaxel/trastuzumab/pertuzumab (AC-TH(P))
  • docetaxel/carboplatin/trastuzumab/pertuzumab (TCH(P))
  • fluorouracil/doxorubicin/cyclophosphamide-docetaxel/trastuzumab/pertuzumab (FAC-TH(P)), or fluorouracil/epirubicin/cyclophosphamide-docetaxel/trastuzumab/pertuzumab (FEC-TH(P)). Note: apart from TCHP, where T is docetaxel, treatment with docetaxel or paclitaxel is acceptable
  • Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Exclusion Criteria
  • Adjuvant treatment with any anti-cancer investigational drug within 28 days prior to registration
  • Stage IV (metastatic) breast cancer
  • Evidence of recurrent disease following preoperative therapy and surgery
  • Current severe, uncontrolled systemic disease
  • Known active and/or untreated hepatitis B or hepatitis C or chronic liver disease. Patients with a diagnosis of hepatitis B or C that has been treated and cleared and normal liver function are eligible to participate in the study if the other eligibility parameters are met.

Keywords and/or Specific Medical Conditions
  • Breast Cancer
  • Oncology (Adult)
KP Clinical Facility
  • Burke Medical Center
  • Capitol Hill Medical Center
  • Gaithersburg Medical Center
  • Largo Medical Center
  • Tyson's Corner Medical Center
  • Woodlawn Medical Center
Clinical Area
  • Oncology (Adult)

Principal Investigator:
Leon Hwang, MD
Contact Information:
- Leslie Greenberg
-Gaithersburg Medical Center

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